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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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hyprocure ii Graham Medical Technologies, LLC Dba Gramedica k142534 10/03/2014
revel spacers Globus Medical, Inc. k180909 12/18/2018
regan-lowe agar Gibco Laboratories Life Technologies, Inc. k861734 05/16/1986
estacore-pro automatic biopsy needle, geotek semiautomatic biopsy needle, maxicore-m automatic biopsy gun needle, maxicore-m automatic biopsy needle and instrument Geotek Medikal Ltd Sti k223300 04/21/2023
geon digital clinical thermometer Geon Corp. k003223 01/12/2001
micro-processor unit #a3600ac General Electric Co. k801762 08/27/1980
digital fluorographic x-ray system General Electric Co. k833530 11/21/1983
geistlich mucograft: 15 x 20 mm, 20 x 30 mm, 8 mm diameter Geistlich Pharma AG k140518 07/18/2014
geiger needle adapter, model 406 Geiger Medical Technologies, Inc. k001029 05/23/2000
ge logiq 700 Ge Medical Systems, Inc. k000516 04/19/2000

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